An E-health Psychoeducation for People With Bipolar Disorders

NCT ID: NCT06296784

Last Updated: 2024-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-26

Study Completion Date

2021-11-15

Brief Summary

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This study aims to present data on the improvement of Quality of life (QoL), biological rhythms, anxiety, depressive symptoms and the correlations between QoL and biorhythms following an e-health psychoeducational intervention for Bipolar Disoirder (BD) during Covid-19 pandemic

Detailed Description

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Biological rhythms significantly impact individuals' quality of life (QoL). During the COVID-19 pandemic, social rhythm dysregulation was identified as a contributing factor to relapses in Bipolar Disorder (BD). This trial aims to present data on the efficacy of an e-health psychoeducational intervention for BD in improving anxiety, depressive symptoms, QoL, biological rhythms, and the correlations between QoL and biorhythms.

This study employs a cross-over randomized controlled trial design. Inclusion criteria include a diagnosis of BD according to Diagnostic and Statistical Manual of mental disorders (DSM-V) criteria, age over 18, and obtaining informed consent.

The intervention consists of e-health psychoeducation aimed at reducing distress levels associated with the Covid-19 pandemic and the implemented restrictive measures (lockdown). The focus is on strategies to manage the dysregulation of biological rhythms, with one session per week over two months. Each session lasts approximately an hour and a half and is conducted by a team comprising psychologists, psychiatric rehabilitation technicians, and professional health educators.

Conditions

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Bipolar Disorder Psychoeducation COVID-19 Pandemic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Open-label cross-over randomized controlled trial (two arms)
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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e-health psychoeducation

Group Type EXPERIMENTAL

e-health psychoeducation

Intervention Type OTHER

e-health psychoeducation intervention provides information about BD clinical condition and symptoms, as well as identifying effective coping strategies to manage symptoms and the dysregulation of biological rhythms. The content covered the impact of the pandemic and its related restrictions on mental health, particularly on anxiety and depressive symptoms. The intervention comprised one session per week for two months, and each session lasted approximately an hour and a half. It was conducted by healthcare professionals.

waiting list

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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e-health psychoeducation

e-health psychoeducation intervention provides information about BD clinical condition and symptoms, as well as identifying effective coping strategies to manage symptoms and the dysregulation of biological rhythms. The content covered the impact of the pandemic and its related restrictions on mental health, particularly on anxiety and depressive symptoms. The intervention comprised one session per week for two months, and each session lasted approximately an hour and a half. It was conducted by healthcare professionals.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* diagnosis of BD according to DSM-V, over 18 years old

Exclusion Criteria

* do not have bipolar disorder, refusal to participate in the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alessandra Perra

UNKNOWN

Sponsor Role collaborator

University of Cagliari

OTHER

Sponsor Role lead

Responsible Party

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Mauro Giovanni Carta

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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San Giovanni di Dio Hospital

Cagliari, CA, Italy

Site Status

Countries

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Italy

Other Identifiers

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PG/2021/8551

Identifier Type: -

Identifier Source: org_study_id

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